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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2009
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract

Data source

Reference
Reference Type:
other: Colipa Preasentation, SCANCOS Conference
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Objective of study:
absorption
metabolism
toxicokinetics
Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 417 (Toxicokinetics)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 4-hydroxybenzoate
EC Number:
202-785-7
EC Name:
Methyl 4-hydroxybenzoate
Cas Number:
99-76-3
Molecular formula:
C8H8O3
IUPAC Name:
methyl 4-hydroxybenzoate
Details on test material:
no data
Radiolabelling:
yes
Remarks:
[14C]-label at Phenyl moiety

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
12 male and 12 female rats
no further data

Administration / exposure

Route of administration:
dermal
Vehicle:
not specified
Details on exposure:
Groups of 12 male and 12 female rats received a single dermal administration of 100 mg/kg bw [14C]-labelled Methylparaben.
Duration and frequency of treatment / exposure:
1 single application
Doses / concentrations
Remarks:
Doses / Concentrations:
100 mg/kg bw
No. of animals per sex per dose / concentration:
12
Control animals:
no
Positive control reference chemical:
None
Details on study design:
Please refer to "Details on exposure" and "Details on dosing and sampling"
Rats were sacrificed 168 h after application and radioactivity analysed in major organs and tissues
Plasma metabolites were investigated by HPLC/UV/radioactivity monitoring
Details on dosing and sampling:
Blood samples were taken at 0, 0.5, 1, 2, 4, 8, 12, 22 and 24 h after treatment
Urine and faeces was examined up to 168 h after application
Statistics:
no data

Results and discussion

Preliminary studies:
None

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Dermal absorption:
14% in males
26% in females

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Methylparaben was completely metabolised to 4-Hydroxybenzoic acid. No systemic exposure was detected to Methylparaben 8 h after dermal application.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Methylparaben was partially absorbed after dermal administration to rats (14% in males, 26% in females). The plasma concentrations consisted entirely of 4 -Hydroxybenzoic acid
Executive summary:

Groups of 12 male and 12 female rats received a single dermal administration of 100 mg/kg bw [14C]-labelled Methylparaben.Blood samples were taken at 0, 0.5, 1, 2, 4, 8, 12, 22 and 24 h after treatment. Urine and faeces was examined up to 168 h after application. Methylparaben was partially absorbed after dermal administration to rats (14% in males, 26% in females). The plasma concentrations consisted entirely of 4 -Hydroxybenzoic acid (the metabolite).